CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Adempas (riociguat) — Coverage Criteria for PAH and CTEPH

Defines medical necessity criteria, prescriber requirements, and authorization durations for riociguat (Adempas) for PAH and CTEPH for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAdempas (riociguat) — Coverage Criteria for PAH and CTEPH

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with right heart catheterization hemodynamics and imaging to support PAH or CTEPH diagnosis for up to 12 months of coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsAuthorization period specified for initial and continuation therapy

WHO Group 1PAH indication group

WHO Group 4CTEPH indication group

mPAP > 20Hemodynamic threshold for PAH/CTEPH diagnosis

Coverage Criteria for Riociguat (Adempas)

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Initial PAH therapy

Authorization of 12 months may be granted for treatment of PAH when ALL of the following criteria are met:

PAH initial criteria: Member has pulmonary arterial hypertension defined as WHO Group class of pulmonary hypertension (Refer to Appendix).

Hemodynamic threshold - mPAP: Mean pulmonary arterial pressure (mPAP) > 20 mmHg.mPAP > 20 mmHg

Right heart catheterization confirmation: PAH was confirmed by right heart catheterization with pretreatment pulmonary capillary wedge pressure (PCWP) < 15 mmHg and pulmonary vascular resistance (PVR) ≥ 3 Wood units.PCWP < 15 mmHg; PVR ≥ 3 Wood units

Initial CTEPH therapy

Authorization of 12 months may be granted for treatment of CTEPH when ALL of the following criteria are met:

CTEPH pathway: Member meets either (i) or (ii): (i) Recurrent or persistent CTEPH after pulmonary endarterectomy (PEA) with supporting imaging (CT or MRI angiography or pulmonary angiography); OR (ii) Inoperable CTEPH with diagnosis confirmed by BOTH imaging and pretreatment right heart catheterization demonstrating PCWP < 15 mmHg, mPAP > 20 mmHg, and PVR > 3 Wood units.mPAP > 20 mmHg; PCWP < 15 mmHg; PVR > 3 Wood units

Either post-PEA persistent/recurrent disease or inoperable disease pathway acceptable.

Continuation therapy

Continuation of therapy

Continuation criteria: Member is currently receiving riociguat through a paid pharmacy or medical benefit; authorization may be granted for 12 months when the member is experiencing benefit from therapy as evidenced by disease stability or disease improvement.evidence of stability or improvement

Applies to members already on therapy.

Prescriber Requirements and Prior Authorization Actions

Prior Authorization

Prior Authorization and Duration

Prior authorization is required. Authorization for up to 12 months may be granted when all listed clinical criteria are met for FDA‑approved indications of riociguat (PAH, WHO Group 1) or CTEPH (WHO Group 4). Continuation requests for members already receiving riociguat may be authorized for 12 months when the member has clinical benefit demonstrated by disease stability or improvement.

Duration: up to 12 months at initial approval
Continuation: 12 months when member is currently receiving medication through a paid benefit and shows clinical benefit (disease stability or improvement)

Background

Riociguat (Adempas) is a soluble guanylate cyclase stimulator indicated to improve exercise capacity and WHO functional class in adults with pulmonary arterial hypertension (PAH, WHO Group 1), and to improve exercise capacity and WHO functional class in adults with persistent/recurrent or inoperable chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4). Efficacy for PAH was demonstrated as monotherapy and in combination with endothelin receptor antagonists or prostanoids in predominantly WHO functional class II–III patients. Hemodynamic confirmation with right heart catheterization is required to establish PAH or inoperable CTEPH prior to authorization, and treatment courses are authorized per policy when the specified diagnostic and hemodynamic criteria are met.

Definitions: PAH and CTEPH (WHO Groups)

PAH (WHO Group 1) — definition and hemodynamic criteria

Clinical groupPulmonary arterial hypertension (PAH), WHO Group 1

Hemodynamic confirmationmPAP > 20 mmHg confirmed by right heart catheterization

Additional RHC criteriaPCWP < 15 mmHg and PVR ≥ 3 Wood units

Indication purposeTo improve exercise capacity, WHO functional class and delay clinical worsening

CTEPH (WHO Group 4) — definition, imaging, and operability

Clinical groupChronic thromboembolic pulmonary hypertension (CTEPH), WHO Group 4

Imaging requirementDiagnosis supported by CT/MRI angiography or pulmonary angiography

Operability pathwaysRecurrent/persistent CTEPH after pulmonary endarterectomy (PEA) OR inoperable CTEPH

Hemodynamic confirmation for inoperable diseasePretreatment right heart catheterization showing mPAP > 20 mmHg, PCWP < 15 mmHg, and PVR > 3 Wood units